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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K012641
Device Name FAS ENDOLUMINAL BRUSH
Applicant
FAS MEDICAL LTD.
PO BOX 219
INDIAN HILLS,  CO 
Applicant Contact THOMAS KROENKE
Correspondent
FAS MEDICAL LTD.
PO BOX 219
INDIAN HILLS,  CO 
Correspondent Contact THOMAS KROENKE
Regulation Number880.5970
Classification Product Code
LJS  
Date Received08/13/2001
Decision Date 10/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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